Act as a member of the Boston Scientific Cork Materials Manaement quality team. To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant. The Quality Engineer will play a key part in leading performance improvement of both inbound and outbound process by engaging and working with a cross functional team to ensure adequate procedures and processes in place to consistently meet Boston Scientific’s requirements
- Supervision of Quality Technicians and QC Inspectors.
- Be the Subject Matter Experts regarding Acceptable Quality Standards for products and processes.
- Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers. Participates in determining goals and objectives for projects.
- Drive and implement process improvements to ensure predictable processes across all areas of the Materials Management area(e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
- Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
- Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s).
- Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
- Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
- Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
- Approval of change requests for product, process and quality system changes.
- Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
- MRB: Review of MRB trends and identification of appropriate corrective actions when required.
- Perform internal quality audits.
- Support the implementation of Lean Manufacturing across the site.
- Transfer and implement product and processes from development or from another manufacturing facility.
- 2-5 years’ experience in Manufacturing or Quality with a Level 8 qualification in Engineering or related technical/Quality discipline.
- Excellent written and verbal communication skills
- Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems
- Strong command of MS Office – Word, Excel, PowerPoint.
- Ability to rapidly learn and use new applications
- Previous experience in a Quality, or Manufacturing background, particularly in relation to incoming inspection
- Experience in the medical device industry
- Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls
- Lead auditor certification ISO 13485 or previous auditing experience.
- Experience in problem solving and process improvement methodologies
- Process Validation, Risk Management, CAPA experience.
We are committed to providing access to opportunities at Boston Scientific for all applicants. If you have a disability and require supported assistance and you would like to talk about potential accommodations related to applying for employment at Boston Scientific Cork, please contact me directly for a confidential discussion Corkrequisitions@bsci.com. Tel No: 021-4531182.